21 results · 38ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

Atalante

FDA 510(k)
FDA Class 2 ·Physical Medicine

WRIST IMPLANT

FDA 510(k)
FDA Class 2 ·Orthopedic

TYSHAK NUCLEUS

FDA 510(k)
FDA Class 2 ·Cardiovascular

ONE TOUCH ULTRA METER

FDA Adverse Event
Injury ·LIFESCAN, INC.·Product code NBW·November 3, 2008

POWER PRO AMBULANCE COT

FDA Adverse Event
Malfunction ·STRYKER MEDICAL·Product code INK·July 21, 2011

CONSTELLATION VISION SYSTEM

FDA Adverse Event
Malfunction ·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·July 9, 2013

GMK SPHERE CEMENTLESS

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code MBH·May 25, 2026

GMK SPHERE TOTAL KNEE SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·November 21, 2024

GMK SPHERE TOTAL KNEE SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·May 5, 2025

GMK 3D METAL TIBIAL TRAY

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·August 6, 2025

GMK SPHERIKA CEMENTLESS

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code MBH·December 19, 2025

GMK SPHERIKA CEMENTLESS

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code MBH·December 24, 2025

GMK 3D METAL TIBIAL TRAY

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code MBH·January 23, 2026

GMK 3D METAL TIBIAL TRAY

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·July 11, 2025

GMK SPHERE TOTAL KNEE SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·December 19, 2024

GMK SPHERIKA CEMENTLESS

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code MBH·January 24, 2025

GMK 3D METAL TIBIAL TRAY

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·September 29, 2025

GMK TOTAL KNEE SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·August 26, 2025

GMK SPHERE TOTAL KNEE SYSTEM

FDA Adverse Event
Malfunction ·MEDACTA INTERNATIONAL SA·Product code JWH·April 15, 2026

GMK 3D METAL TIBIAL TRAY

FDA Adverse Event
Death ·MEDACTA INTERNATIONAL SA·Product code JWH·January 19, 2026